Clinical trial on left heart assist system TRE-689

UMIN ID: UMIN000001387

Registered date:22/09/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: End Stage Heart Failure
• Date of first enrollment: 2008/10/01
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Implantation of TRE-689

Outcome(s)

• Primary Outcome: 1. Efficacy endpoints (1) Success or failure of implantation (2) Survival or death of patient (3) QOL and NYHA cardiac function class (4) Pump function (5) Duration of assisted circulation (in days) 2. Safety endpoints (1) Time course of indicators of blood coagulation (2) Breakage or malfunction of the device (3) Adverse event and Device-related Adverse event (4) Major and serious adverse events (5) Time course of vital signs, laboratory parameters (hematology, BNP and biochemistry) and psychiatric test data (depression scale and emotional disorder scale)

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: Patients falling under any of the following criteria at the time of registration are excluded from this study: (1)Patients with severely compromised function of the right half of the heart system; (2)Patients with moderate or severer aortic valve insufficiency or with a prosthetic aortic valve; (3)Patients with severe calcification of the ascending or descending thoracic aorta; (4)Patients with severe infection, testing positively in blood culture or showing elevated body temperature (over 38oC); (5)Patients with irreversible failure of any other than the heart; (6)Patients with severe chronic obstructive pulmonary disease; (7)Patients having developed marked pulmonary artery embolism within 30 days before registration; (8)Patients with severe pulmonary hypertension; (9)Patients with gastrointestinal inflammation, severe hypertension, severe diabetes mellitus or the like; (10)Patients having developed myocardial infarction within 30 days before registration; (11)Patients having received open heart surgery very recently (within 2 weeks before registration); (12)Patients with severe disorders of the central nervous system; (13)Patients with severe cerebrovascular disease; (14)Patients complicated by malignant disease with poor prognosis; (15)Markedly obese patients; (16)Patients complicated by systemic disease (collagen disease, etc.); (17)Patients with a history of neuropsychiatric disease severe enough to make it impossible to follow or understand the protocol; (18)Pregnant or possibly pregnant patients; (19)Patients with a history of heparin-induced thrombopenia or with severe hematological disorders (hemorrhagic tendency, clotting disorder, etc.); (20)Patients with a history of drug or alcohol addiction; (21)Patients having completed any other clinical trial within 6 months before registration; (22)Patients rated by the investigator or sub-investigator as inappropriate for the study.

Related Information

• Primary Sponsor: Terumo Corporation
• Source(s) of Monetary Support: Terumo Corporation